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6 6 Medical Necessity “Medical Necessity”  A U.S. legal doctrine, related to medical activities that may be justified as reasonable, necessary, and/or appropriate, based on evidence-based clinical “standards of care.”  Generally covered by Medicare/Medicaid  Ethically speaking, a person has a right to advance his or her own welfare by consenting or by refusing consent to any treatment

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7 7 Medical Futility Two prevailing definitions  Virtual certainty that a Rx will fail to achieve a specific physiologic effect (physiologic)  Virtual certainty that a Rx, though it will have a physiologic effect, will not result in a sufficient benefit to the patient (normative)  Immanent demise futility, lethal condition futility, qualitative futility

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8 8 Medical Futility Formal Similarities  An identified goal  A particular Rx aimed at that goal  Virtual certainty that the Rx will not be successful in attaining that goal  The difference is in the nature of the goals & their corresponding forms of judgment

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10 Medical Futility Preferable Definition Virtual certainty that the treatment in question either will not be successful in attaining the mutually agreed upon goals of treatment or will not be successful in achieving the treatment’s somatic effect Normative Physiologic

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11 Application Implications  Whether a particular treatment is futile or beneficial is always in reference to a particular goal  “Care” is never futile, only particular Rx  Foregoing a beneficial Rx does not necessarily imply withdrawing care  Simply because a Rx is beneficial does not automatically imply that it is morally obligatory  Futility cases almost always entail a conflict over the value of a particular effect, but not over the probability of the effect  Need to distinguish between & acknowledge normative & clinical realms of reasoning

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12 Application Unilateral Physician decisions to discontinue Rx should be  limited to physiologically ineffective Rx  supported by clinical experience & research  discussed with pt/family early, in context of goals Physician decisions to initiate or continue Rx should be made  when there is presumed consent (emergency)  or only with informed consent of patient/surrogate  discussed with pt/family early, in context of goals

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13 Application Neither “futility” nor “medical necessity” should be used to end conversation  Not respectful of pt. autonomy  Ignores the need to address root cause of disagreement

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15 Communicating with Integrity Tips for Communicating  Begin communicating early & often  Focus on Goals of Treatment  Be consistent – keep team engaged  Choose language carefully  Be sensitive to cultural differences  Be aware of and acknowledge own biases

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16 Ethical and Religious Directives “A person in need of health care and the professional health care provider who accepts that person as a patient enter into a relationship that requires, among other things, mutual respect, trust, honesty, and appropriate confidentiality. The resulting free exchange of information must avoid manipulation, intimidation, or condescension…Neither the health care professional nor the patient acts independently of the other; both participate in the healing process.” - ERDs, Part Three, Introduction

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17 Conclusion In cases of conflict re value of goals  Ethics consultation may help clarify issues, raise alternatives/compromises, provide institutional perspective and support  Dr. has right to withdraw, if competent and willing substitute will accept transfer  If no substitute, appeal to society through appropriate legal means